PLYMOUTH MEETING, PA — Braeburn announced that results from a National Institutes of Health-funded clinical trial evaluating a weekly extended-release buprenorphine treatment for opioid use disorder in pregnancy were published in JAMA Internal Medicine.
The multisite randomized trial, conducted from July 2020 to November 2024 at 13 U.S. locations, compared a weekly extended-release formulation of buprenorphine with standard sublingual buprenorphine in pregnant and postpartum individuals.
The study found that the extended-release treatment met its primary goal of noninferiority and showed higher rates of illicit opioid abstinence during pregnancy compared with the sublingual form, according to the publication.
Researchers reported abstinence rates of 82.5% for the extended-release group versus 72.6% for the sublingual group during pregnancy, while postpartum outcomes were similar between the two groups.
Serious adverse events were reported less frequently among participants receiving the extended-release treatment during both pregnancy and postpartum periods, while rates of non-serious adverse events were similar across both groups.
“The trial results support the use of weekly extended-release buprenorphine for treating pregnant individuals with opioid use disorder,” said John Winhusen, lead author of the study and professor of psychiatry and behavioral neuroscience at the University of Cincinnati College of Medicine.
The study, known as the MOMs trial, enrolled 140 participants who were randomly assigned to either the extended-release or sublingual treatment groups.
Researchers noted limitations including data constraints affecting some secondary outcomes, differences in scoring methods across study sites, and limited diversity among participants.
Opioid use disorder affects an estimated 2% to 3% of pregnancies in the United States, based on national Medicaid data cited in the study.
The full study, titled “Extended-release versus Sublingual Buprenorphine for Opioid Use Disorder in Pregnancy through 12-months Postpartum,” is available through JAMA Internal Medicine.
BRIXADI, the extended-release buprenorphine product evaluated in the study, is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated or are already receiving buprenorphine therapy.
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